Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Research Objectives and Scope

This notice of funding opportunity (NOFO) aims to support research and development – from early-stage discovery through advanced product development – aimed at diagnosing, mitigating, and treating radiation- or chemical-induced injuries, or internal radionuclide contamination during and after mass-casualty public health emergencies. The goal of this initiative is to enable academic and industry partners to develop triage tools and safe, effective medical countermeasures (MCMs) to protect United States (U.S.) citizens and save lives during radiological, nuclear, or chemical incidents.

Each application must address only one Research Area listed below:

• Research Area 1: Radiation MCMs, models, and natural history
• Research Area 2: Biodosimetry
• Research Area 3: Nonhuman Primate (NHP) Radiation Survivor Cohort (NHP-RSC)
• Research Area 4: Chemical Countermeasures

All Research Areas aim to support animal models and new approach methodologies (NAMs) such as improved in-silico predictive models and in vitro platforms (e.g., microphysiological systems) to complement and/or reduce the use of animal models to assess radiation or chemical injury natural history, biomarkers, and MCM safety and efficacy.

Research Area 1 - Radiation MCMs, models, and natural history
This Research Area seeks MCM development and aims to support, but is not limited to, the following topic examples:

• Research and development on MCMs given after radiation exposure with administration of the first dose beginning at a minimum of 24 hours or later post-irradiation (48 hours or later for neutropenia or thrombocytopenia-targeted hematopoietic-ARS products), for treatment of acute radiation syndrome (ARS) and/or delayed effects of exposure, including:
  • Products to enhance survival and/or reduce major morbidities in irradiated models or NAMs predictive of human responses, or for decorporation agents, to reduce body burden of internalized radionuclides.
• Product development to support U. S. Food and Drug Administration (FDA) interactions and facilitate licensure and potential inclusion in the Strategic National Stockpile.
• Development of artificial intelligence (AI)/machine learning (ML) methods for identification of novel targets and/or lead molecules for radiation injuries, interpretation of complex data sets, and/or data mining to identify biomarkers altered by irradiation and/or MCM treatment.

Research Area 2 – Biodosimetry
This Research Area aims to support the development of biodosimetry approaches/devices for triage and/or predictive biodosimetry of early and late injuries to facilitate determination of radiation exposure status (yes/no field deployable triage applications), as well as to guide medical care. This Research Area aims to support, but is not limited to, the following topics:

• Evaluation of radiation injury biomarker signatures predictive of early and/or delayed injury with signature biokinetics analysis within 30 minutes to days, weeks, or months of radiation exposure.
• Development of point-of-care (e.g., field triage) or definitive care (e.g., medical center based) biodosimetry signature/device to measure intensity of radiation injuries.
• Influence of confounders on the kinetics of the biomarker(s) should be considered (e.g., type of radiation, percent of body exposure, use of FDA approved products).

Research Area 3 - Nonhuman primate radiation survivor cohort (NHP-RSC)
This Research Area aims to support the following:

• Support of an existing NHP-RSC of 200 or more male and female irradiated (1-14 Gy, total- or partial-body exposed) and non-irradiated control animals: rhesus macaques (Macaca mulatta) or cynomolgus macaques (Macaca fascicularis).
• Collecting, cataloging, archiving, and sharing biological and data resources, as well as computational resources to conduct in-depth analyses of health data.

Research Area 4 - Chemical Countermeasures (CC)
This Research Area supports discovery and early development of CC against U.S. Government-designated Chemicals of Concern (CoCs). CoCs are grouped into toxidromes based on their primary mechanisms of toxicity, enabling the development of threat agnostic MCMs. The examples below highlight CoCs of interest to the Government.

CoC toxidromes (with examples of associated CoCs) include:

• Anticoagulants: brodifacoum, bromadiolone
• Blood Agents: hydrogen cyanide, hydrogen sulfide
• Cholinergic: parathion, phorate, aldicarb
• Convulsants: picrotoxin, TETS, strychnine
• Hemolytic/Metabolic Agents: arsenic trioxide, thallium sulfate, arsine
• Pulmonary Irritant/Corrosive Agents: chlorine, phosgene, ammonia
• Ultra-Potent Synthetic Opioids: fentanyl, carfentanil, nitazenes
• Vesicants: nitrogen mustard, phosgene oxime

Research topics include:

• Validating targets and pathways; characterizing preliminary candidates; optimizing hits to leads; and demonstrating post-exposure activity in models that predict human response in mass-casualty settings.
• Developing therapeutics (including repurposed drugs) to:
  • Mitigate acute, life-threatening effects in mass-casualty settings.
  • Prevent long-term or delayed harmful health effects following acute exposure (i.e., improve quality of life).

Non-Responsive Criteria for All Applications

Applications that meet any of the criteria below will be considered non-responsive and will not be reviewed:

• Research proposing pretreatment approaches, i.e., compound(s) that must be administered prior to radiation/chemical exposure to be protective/efficacious (prophylaxis)
• Proposed HIV/AIDS research
• Epidemiological studies
• Applications proposing research in more than one research area within a single application

Additional Research Area Specific Non-Responsive Criteria

Research Areas 1-3: Radiation and Nuclear Countermeasures Applications with studies that –

• Propose administration of a candidate MCM at times earlier than 24 hours after radiation exposure (or earlier than 48 hours for MCMs targeting neutropenia or thrombocytopenia resulting from radiation exposure).
• Characterize and develop biomarkers of carcinogenesis.
• Utilize non-biologically based dosimetric methods and/or environmental testing/sampling devices (e.g., thermo-luminescent detectors, fortuitous dosimeters, and radiation portals).

Research Area 4: Chemical Countermeasures Applications with studies that –

• Propose research that does not create or validate candidate MCMs efficacy against CoCs.
• Address chronic, long-term environment or occupational CoC exposures.
• Propose therapeutics that are not feasible for mass-casualty use, including those requiring treatment within 15–30 minutes of exposure, except for therapeutics targeting ultra-potent synthetic opioids.
• Develop environmental decontamination methods or diagnostic, triage, or analytical technologies.
• Advance product development activities for CoC MCMs, including GLP IND-enabling studies, pivotal animal efficacy studies, or cGMP manufacturing.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions - Includes all types

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized).

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Facilities & Other Resources: For applications addressing Research Area 3 - NHP-RSC, describe the following:

Availability of laboratory space and the ability to support the following NHP studies and testing:

• Pathology and necropsy (to include histology and immunohistochemistry) and sample imaging
• Physiological testing (e.g. cardiac and respiratory, endocrine and metabolic; microbiome, immune surveillance and other aspects of immune function/vaccine response, neurologic and behavioral assessments, etc.)
• Standard analyses such as serum chemistries, blood counts, as well as molecular and cellular analyses and radiographic exams (e.g. x-rays, CTs, MRIs) and other imaging studies to evaluate animal health status.

Provision of safe and reliable NHP transport to and from the site for accrual and evaluations in compliance with U. S. Department of Agriculture (USDA) Animal Welfare Act (AWA) transportation regulations.

Describe Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited NHP facilities with adequate housing and caging, including indoor and outdoor access.

Since the proposed work involves the use of NHPs, which are USDA-regulated species, each organization will have to register with the USDA and agree to comply with the AWA and annual inspections. If currently licensed or registered, please provide the license or registration number for each facility. 

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

Within the Biographical Sketch Common Form of Key personnel proposing research related to radiation and nuclear countermeasures, describe expertise within the areas of radiation biology, dosimetry/health physics, statistics, drug/device development, biostatistics, and veterinary medicine (if animal studies are proposed) including AAALAC accredited veterinary experience handling irradiated NHPs if proposing radiation related research involving NHPs.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions for applications to Research Areas 1-3:

For Research Areas 1-3: Within the budget section, include funds to support travel for the PD(s)/PI(s), and if necessary, the minimum number of additional relevant staff, to participate in a once yearly, 1-day program progress meeting with NIAID, to be held in the Rockville, MD area.

For Research Area 3 - NHP-RSC applications, include the following: A detailed budget not to exceed $2M in direct costs in the first year of the award. Applicants should also assume that up to 25 animals may be added to the cohort each year from other government-funded studies. These animals will be designated by NIAID staff, in conjunction with the PD(s)/PI(s).

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: State which Research Area (1, 2, 3, or 4) the application addresses. List in priority order the broad, long-range objectives and goals of the proposed project. Concisely describe the work to be completed.

Research Strategy: Use this section to summarize the research strategy, including significance, innovation and approach and explain the rationale for selecting the methods to accomplish the specific aims.

All applications regardless of Research Area should address the following:

• Describe well-defined, rigorous experimental methods that support the proposed indication, with a clear concept of use in mass-casualty or emergency settings. Provide a clear justification for biomarker(s) selection, model and endpoint selection, controls, timing, route of administration or sample selection if applicable.
• Provide a clear and feasible development plan, with associated timeline(s), that outlines key activities.

Benchmarks: Applicants should include a table of benchmarks reflecting the high-risk, progressive nature of product development research. Benchmarks should include:

• Quantitative benchmarks for assessing year-one progress, and clearly defined out-year interim objectives.

Prior to award of each budget period, benchmarks may be renegotiated. Failure to meet benchmarks may affect non-competing continuation awards.

Applications that do not include annual benchmarks for assessing successful progress will be considered non-compliant and will not be reviewed.

For applications focused on MCMs (radiological, nuclear or chemical), describe the following:

• Based on robust preliminary data, describe the therapeutic candidate, including full chemical structure when applicable. Explain how the proposed MCM will advance a well-characterized candidate to reduce mortality and morbidity in mass casualty events, and, when relevant, how it improves upon current standard of care. These efforts incorporate a clearly defined concept of use, continuum of care (e.g., field to hospital), and route of administration to ensure the innovation is practical and deployable.
• Describe the novelty of the proposed therapeutic candidate or approach, clearly identify what is innovative about the target, pathway, mechanism, assays, or models. If proposing drug repurposing, provide a strong scientific rationale for the new indication. If the candidate builds upon or improves an earlier, unmarketed drug, clearly describe its advantages and summarize relevant preclinical and clinical findings that support continued development of the proposed candidate.
• Describe how the project will demonstrate that the candidate MCM, including repurposed therapeutics, is biologically active, synthetically feasible, has defined specificity, potency, target selectivity, pharmacokinetic/pharmacodynamic (PK/PD) properties, safety, and clinically relevant post-exposure in vivo efficacy.

Applications that do not include preliminary data supporting intended use/target pathology will be considered non-compliant and will not be reviewed.

Research Area 1 – Radiation MCMs, models, and natural history:

• Describe how the application focuses on basic or translational research aimed at the development of an MCM at timepoints 24 hours (or 48 hours for thrombocytopenia or neutropenia H-ARS targeted products) or later post-irradiation.

Research Area 2 – Biodosimetry:

• Provide preliminary data for the intended end-use (triage, dose determination, and/or predictive biodosimetry). Describe the research gap the application addresses. For example, distinguish between concerned citizens (unexposed) and exposed populations, determining the radiation dose of an exposed individual, or determining the acute and/or delayed radiation injury outcomes to major organs/physiological systems. 

Applications that do not include preliminary data supporting intended use/target pathology will be considered non-compliant and will not be reviewed.

Research Area 3 – NHP-RSC:

• Describe what samples will be archived from the animals, and what data will be preserved. Applicants should assume that any diagnostics that they proposed to carry out, and/or standard medical management and treatment(s) provided to the animals in the cohort should be consistent with treatment(s) provided to humans with similar symptoms.

Research Area 4 – Chemical Countermeasures:

• Describe how the application focuses on translational research to develop a mass-casualty appropriate delayed treatment CoC MCM. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

 Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the  How to Apply – Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the  How to Apply – Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Requests for reconsideration of initial peer review will not be accepted for applications submitted in response to this NOFO. 

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Diseases Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant's federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant's integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient's business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director's Statement of Priorities, entitled "Advancing NIH's Mission Through a Unified Strategy." 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

For applications involving funding Medication-Assisted Treatment (MAT) or medications for opioid use disorder (MOUD), this funding should be used to provide comprehensive treatment and recovery support services rather than medication-only models for opioid use disorder. Services should include medications, where clinically indicated, in conjunction with psychosocial and other treatment and recovery support services. Funding can also be used to support individualized tapering and discontinuation of medications when clinically indicated. Please see Updated Funding Guidance for Recipients on  MAT/MOUD.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

In administering programs under this and all funding announcements, NIH prioritizes: 

• Research involving rigorous scientific methods, including for studies related to children and adolescents, where NIH is committed to approaches that reflect the highest standards of clinical care and child safety. 
• Biological and physiological integrity: Recognizing the relevance of biological sex to health outcomes, NIH encourages applicants to account for sex-based health factors in program design, data collection, and service delivery where scientifically appropriate.
• NIH will implement these priorities consistent with applicable laws, regulations, court orders, and all required administrative procedures. Applicants are encouraged to describe how their proposed programs align with these priorities in their project narratives. Funded activities must advance NIH's vision of protecting and improving the health and well-being of Americans. The particular focus is on those who are medically vulnerable, or live in areas with limited access to care. NIH's duty is to serve wisely, effectively, and with measurable results that justify every taxpayer dollar invested. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Overseeing/performing the scientific activities.
• Defining the details and goals of the project, including the development of annual benchmarks, which may be renegotiated prior to award.
• Research design and protocol development, data collection, final data analysis and interpretation, preparation of publications, as well as collaboration with other recipients.
• Submission of manuscripts to the NIH Project Scientist right after acceptance for publication so that an up-to-date summary of program accomplishments can be maintained and press conferences and press releases prepared.
• Attendance at annual and/or monthly program meetings.
• In the case where the benchmarks are not met, setting and implementing corrective plans that will be negotiated with, and subject to, approval by NIH.
• For Research Areas 1-3 awards, participation in a NIAID-sponsored, program-wide dosimetry harmonization effort.
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• If benchmarks are not met during the course of the project period, provide guidance for remediation of the benchmarks in support of successful completion of the project.
• Advise in the selection of sources or resources (e.g., determining where a particular reagent may be found, identifying animals to be considered for inclusion in the NHP-RSC); provide advice and guidance on technical issues; coordinate or participate in the collection and/or analysis of data; and advise on the management and technical performance.
• Aid in organizing and will provide scientific guidance in annual and monthly meetings.
• Provide scientific input toward the preparation of publications and collaborations with, and access to, other NIH-supported research resources and services, as needed.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Participate in monthly and annual meetings to facilitate the achievement of program goals.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the recipient, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format. Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. 

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

National Institute of Allergy and Infectious Diseases (NIAID)
Email: RADCHEM_U01@mail.nih.gov

National Eye Institute (NEI)
Email: NEI_extramural@nih.gov

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
E-mail: niams_ccrp@mail.nih.gov 

National Institute of Drug Abuse (NIDA)
Email: nidacppprogram@mail.nih.gov 

National Institute of Neurological Disorders and Stroke (NINDS)
Email: nindsonetox@ninds.nih.gov  

Division of Lung Diseases
National Heart, Lung, and Blood Institute (NHLBI)
Email: nhlbidld_grants@nhlbi.nih.gov
Subject: RFA-AI-27-014

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

National Institute of Allergy and Infectious Diseases (NIAID)
Email: niaidfinancial-grantscontact@mail.nih.gov  

National Eye Institute (NEI)
Email: NEI_extramural@nih.gov 

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 
E-mail: niamsgrants@nih.gov 

National Institute of Drug Abuse (NIDA) 
Email: nidagmbemail@nida.nih.gov 

National Institute of Neurological Disorders and Stroke (NINDS)
Email: chiefgrantsmanagementofficer@ninds.nih.gov  

Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Subject: RFA-AI-27-014
 

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.